Device for staunching postpartum haemorrhage

Abstract

A device ( 1 ) for staunching postpartum haemorrhage of the uterus (U). The device ( 1 ) comprises an inflatable internal balloon ( 2 ) having an inlet connected by a fitting ( 3 ) over a distal end ( 4 ) of a tubular conduit ( 5 ). The tubular conduit ( 5 ) has a proximal end ( 6 ) for connection to an inflation source for manually inflating the internal balloon ( 2 ). A non-return valve ( 8 ) is fitted in the conduit ( 5 ) at the proximal end ( 6 ). The device ( 1 ) has an inflatable external balloon ( 10 ) for indicating when the surface of the internal balloon ( 2 ) has engaged with the wall of the uterus (U). The external balloon ( 10 ) also acts as an indicator to indicate subsequent contraction of the uterus (U).

1 - 47 . (canceled)  
   
   
       48 . A device for staunching postpartum haemorrhage comprising: 
 an internal balloon for insertion into a uterus;    the internal balloon being inflatable to engage the wall of a uterus;    a tubular conduit having a distal end in fluid communication with the internal balloon and a proximal end in fluid communication with an inflation source;    the internal balloon being attached to the tubular conduit at a single attachment region to facilitate unconstrained inflation of the internal balloon; and    a first indicator for indicating when the internal balloon has engaged the wall of a uterus.    
   
   
       49 . The device as claimed in  claim 48  wherein the device comprises a second indicator for indicating subsequent contraction of a uterus.  
   
   
       50 . The device as claimed in claim. 49  wherein the first indicator and the second indicator are provided by a single indicator device.  
   
   
       51 . The device as claimed in  claim 48  wherein the tubular conduit defines a, longitudinal axis, and the internal balloon is inflatable in a direction parallel to the tubular conduit longitudinal axis.  
   
   
       52 . The device as claimed in  claim 51  wherein the internal balloon defines three mutually perpendicular co-ordinate axes, and the internal balloon is inflatable in directions parallel to all three co-ordinate axes.  
   
   
       53 . The device as claimed in  claim 48  wherein the internal balloon comprises an inlet, and the inlet of the internal balloon is attached to the single attachment region of the tubular conduit.  
   
   
       54 . The device as claimed in  claim 53  wherein the internal balloon comprises a continuous balloon wall with a single opening in the balloon wall, the single opening providing the inlet.  
   
   
       55 . The device as claimed in  claim 48  wherein an outer surface of the internal balloon is substantially smooth.  
   
   
       56 . The device as claimed in  claim 48  wherein the indicator is connected in fluid communication with the tubular conduit.  
   
   
       57 . The device as claimed in  claim 56  wherein the tubular conduit comprises an indicator port for connecting the indicator in fluid communication with the tubular conduit.  
   
   
       58 . The device as claimed in  claim 56  wherein the device comprises an external valve intermediate the tubular conduit and the indicator.  
   
   
       59 . The device as claimed in  claim 56  wherein the indicator is inflatable.  
   
   
       60 . The device as claimed in  claim 59  wherein the indicator comprises an external balloon.  
   
   
       61 . The device as claimed in  claim 60  wherein the internal balloon and the external balloon are configured to facilitate inflation of the internal balloon in the event of a defined fluid pressure within the internal balloon and to resist inflation of the external balloon in the event of the same defined fluid pressure within the external balloon.  
   
   
       62 . The device as claimed in  claim 61  wherein the defined pressure is less than or equal to mean arterial pressure.  
   
   
       63 . The device as claimed in  claim 61  wherein the dimensions of the internal balloon and the dimensions of the external balloon are configured to facilitate inflation of the internal balloon in the event of a defined fluid pressure within the internal balloon and to resist inflation of the external balloon in the event of the same defined fluid pressure within the external balloon.  
   
   
       64 . The device as claimed in  claim 63  wherein:  
     
       

       r 
       1 
       /t 
       1 
       >r 
       2 
       /t 
       2  

     
     where: 
 r 1 =radius of the internal balloon when in a static uninflated state.  
 r 2 =radius of the external balloon when in a static uninflated state.  
 t 1 =wall thickness of the internal balloon when in a static uninflated state.  
 t 2 =wall thickness of the external balloon when in a static uninflated state.  
 
   
   
       65 . The device as claimed in  claim 64  wherein the ratio of  
       r 1 /t 1 : r 2 /t 2    
     is at least 2:1.  
   
   
       66 . The device as claimed in  claim 65  wherein the ratio of  
       r 1 /t 1 : r 2 /t 2    
     is approximately 2.5:1.  
   
   
       67 . The device as claimed in  claim 63  wherein the volume of the internal balloon when in a static uninflated state is substantially larger than the volume of the external balloon when in a static uninflated state.  
   
   
       68 . The device as claimed in  claim 67  wherein the ratio of the volume of the internal, balloon when in a static uninflated state to the volume of the external balloon when in a static uninflated state is at least 10:1.  
   
   
       69 . The device as claimed in  claim 68  wherein the ratio is at least 15:1.  
   
   
       70 . The device as claimed in  claim 67  wherein the ratio is approximately 17:1.  
   
   
       71 . The device as claimed in  claim 63  wherein the surface area of the internal balloon when in a static uninflated state is substantially larger than the surface area of the external balloon when in a static uninflated state.  
   
   
       72 . The device as claimed in  claim 71  wherein the ratio of the surface area of the internal balloon when in a static uninflated state to the surface area of the external balloon when in a static uninflated state is at least 5:1.  
   
   
       73 . The device as claimed in  claim 72  wherein the ratio is approximately 7:1.  
   
   
       74 . The device as claimed in  claim 61  wherein the material properties of the internal balloon and the material properties of the external balloon are configured to facilitate inflation of the internal balloon in the event of a defined fluid pressure within the internal balloon and to resist inflation of the external balloon in the event of the same defined fluid pressure within the external balloon.  
   
   
       75 . The device as claimed in  claim 74  wherein:  
       E 1 <E 2    
     where:—E 1 =modulus of elasticity of the internal balloon; 
 E 2 =modulus of elasticity of the external balloon;  
 
   
   
       76 . The device as claimed in  claim 48  wherein the device comprises a connector for attaching the internal balloon to the tubular conduit.  
   
   
       77 . The device as claimed in  claim 76  wherein the connector has a proximal region attached to an outer surface of the tubular conduit, and a distal region attached to an outer surface of the internal balloon.  
   
   
       78 . The device as claimed in  claim 77  wherein the distal region extends substantially tangentially around at least part of the outer surface of the internal balloon.  
   
   
       79 . The device as claimed in  claim 77  wherein the connector tapers outwardly from a proximal end of the connector to a distal end of the connector.  
   
   
       80 . A method of staunching postpartum haemorrhage comprising the steps of: 
 providing a device comprising an internal balloon, a tubular conduit having a distal end in fluid communication with the internal balloon and a proximal end in fluid connection with an inflation source, and a first indicator;    inserting the internal balloon into a uterine cavity;    inflating the internal balloon until the internal balloon engages the wall of the uterus; and    monitoring the first indicator to determine when the internal balloon has engaged the wall of the uterus.    
   
   
       81 . The method as claimed in  claim 80  wherein engagement of the internal balloon with the wall of the uterus causes the first indicator to inflate.  
   
   
       82 . The method as claimed in  claim 81  wherein the first indicator is connected in fluid communication with the tubular conduit.  
   
   
       83 . The method as claimed in  claim 80  wherein the device comprises a second indicator, and the method comprises the step of monitoring the second indicator to determine subsequent contraction of the uterus.  
   
   
       84 . The method as claimed in  claim 83  wherein subsequent contraction of the uterus causes the second indicator to inflate.  
   
   
       85 . The method as claimed in  claim 84  wherein the second indicator is connected in fluid communication with the tubular conduit.  
   
   
       86 . The method as claimed in  claim 83  wherein the first indicator and the second indicator are provided by a single indicator device.  
   
   
       87 . The method as claimed in  claim 80  wherein the method comprises the step of, after engagement of the internal balloon with the wall of the uterus, stopping inflation of the internal balloon.  
   
   
       88 . The method as claimed in  claim 80  wherein the method comprises the step of, after engagement of the internal balloon with the wall of the uterus, further inflating the internal balloon to increase contact pressure between the internal balloon and the wall of the uterus.  
   
   
       89 . The method as claimed in  claim 88  wherein the method comprises the step of disconnecting the indicator from the tubular conduit before further inflating the internal balloon.  
   
   
       90 . The method as claimed in  claim 80  wherein the method comprises the step of, after engagement of the internal balloon with the wall of the uterus, further inflating the indicator.  
   
   
       91 . The method as claimed in  claim 90  wherein the method comprises the step of at least partially deflating the indicator to further inflate the internal balloon to increase contact pressure between the internal balloon and the wall of the uterus.  
   
   
       92 . The method as claimed in  claim 91  wherein the indicator is at least partially deflated by squeezing the indicator.